At Houston Methodist, the Clinical Research Specialist position is responsible for supporting multiple projects under the supervision of the Clinical Trial Manager. This may include clinical research protocols, gathering patient data via methods specified in the study protocol, and study reports. This position ensures accurate data collection, documentation organization, and safety of study volunteers.
PEOPLE ESSENTIAL FUNCTIONS
- Supports the inter-professional team of clinical research investigators, nurses, and coordinators. Promotes a positive work environment and contributes to a dynamic, team-focused work unit that actively helps one another to achieve optimal department results.
- Conducts self in a manner that is congruent with cultural diversity, equity, and inclusion principles. Contributes towards the improvement of department scores for employee engagement, i.e., peer-to-peer accountability.
SERVICE ESSENTIAL FUNCTIONS
- Performs clinical research support functions as assigned by the clinical trial manager, including but not limited to informed consent for non-interventional studies, data abstraction, and recording in CRFs.
- Makes phone calls to study patients for appointment reminders and follow-up.
- Transports blood and tissue samples and processes and packages lab samples for shipping to the sponsor or storage at the site per the study manual of operations.
QUALITY/SAFETY ESSENTIAL FUNCTIONS
- Completes required case report forms and resolves queries. Ensures accurate data collection, documentation organization, and safety of study volunteers. Ensures accurate regulatory filing.
- Assists the Clinical Trial Manager in identifying opportunities for research workflow process improvement, providing recommendations, and contributes to meeting department and hospital targets for quality and safety.
FINANCE ESSENTIAL FUNCTIONS
- Assures study conduct meets appropriate IRB, FDA, ICH, and agency guidelines.
- Utilizes resources with cost-effectiveness and value creation in mind. Self-motivated to independently manage time effectively and prioritize daily tasks, assisting coworkers as needed.
GROWTH/INNOVATION ESSENTIAL FUNCTIONS
- Assists in simple data analysis, with the development of training materials for data reports, systems, and collection and report generation.
- Leads and identifies opportunities for performance improvement. Supports change initiatives and adapts to unexpected changes.
- Seeks opportunities to identify self-development needs and takes appropriate action. Ensures own career discussions occur with appropriate management. Completes and updates the My Development Plan on an ongoing basis.
This job description is not intended to be all-inclusive; the employee will also perform other reasonably related business/job duties as assigned. Houston Methodist reserves the right to revise job duties and responsibilities as the need arises.
EDUCATION
- Bachelor's degree in a related field
- Bachelor's Degree in a Health-Science related field preferred
WORK EXPERIENCE
- One year experience in a healthcare setting preferred
- Research setting preferred
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